An interventional study of Lavender oil and Placebo in Anxiety; Generalized, Breast Diseases and Surgery, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.
Many patients undergoing surgery experience anxiety in the preoperative setting. Pharmacologic anxiolytics require monitoring and cause excess sedation which often interferes with the ability to assess and obtain consent from a patient in the preoperative holding area. Lavender aromatherapy is an alternative treatment for anxiety which is safe, inexpensive, easy to administer, and not overly sedating. In addition to its benefits in the preoperative setting, anxiolysis and reduction in sympathetic drive can lead to reduction in the intraoperative anesthetic and postoperative analgesic requirements. This in turn can lead to faster recovery and expedited discharge from the post anesthesia care unit.
In the proposed study, we would evaluate the efficacy of aromatherapy with lavender oil in reducing anxiety prior to breast surgery. The study group would receive lavender oil preoperatively and the placebo group would receive unscented oil preoperatively. Before and after treatment, anxiety level would be measured using the Spielberger State-Trait Anxiety Inventory. Additionally, vital signs and Bispectral index (BIS) will be measured before and after treatment, as further indicators of anxiety level. We hypothesize that lavender aromatherapy will decrease anxiety and subsequently will reduce blood pressure, heart rate, and BIS.
149 studies on the registry are indexed under Breast Diseases; 25 are open to participants now.
This study's enrollment of 93 is below the median of 123 across 92 interventional studies indexed under Breast Diseases.
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Inclusion Criteria: Female; Age 18+; American Society of Anesthesiologists (ASA) I-III; undergoing elective breast surgery
Exclusion Criteria: Male; History of asthma/bronchitis/Chronic Obstructive Pulmonary Disease (COPD)/contact dermatitis to cosmetic fragrances/pregnancy; significant laboratory abnormalities.
Lavender oil aromatherapy
Other: Lavender oil
Placebo -- unscented oil aromatherapy
Other: Placebo
2 drops for aromatherapy
2 drops unscented mineral oil for aromatherapy
Anxiety Reduction
We hoped to show that lavender aroma therapy reduces preoperative anxiety in patients undergoing breast. The Trait subscale (STAI-TRAID) of the Spielberger State-Trait Anxiety Inventory was administered before and after 10 minutes of aromatherapy treatment pre-surgery. The TRAIT subscale contains 20 questions scored on a Likert scale from 1-4; item scores are summed for a total score ranging from 20 to 80, with higher scores indicating higher anxiety. Change in anxiety was calculated as the score pre-aromatherapy minus the score post-aromatherapy. Higher positive change scores indicate greater reductions in anxiety.
Time frame: 20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)
Patients were recruited from the out-patient surgical unit of New York University (NYU) Langone Medical Center from January 18 - June 11, 2013. Only female patients having breast surgery were approached.
| Milestone | Lavender Oil | Placebo |
|---|---|---|
| Started | 47 | 46 |
| Completed | 45 | 45 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
We hoped to show that lavender aroma therapy reduces preoperative anxiety in patients undergoing breast. The Trait subscale (STAI-TRAID) of the Spielberger State-Trait Anxiety Inventory was administered before and after 10 minutes of aromatherapy treatment pre-surgery. The TRAIT subscale contains 20 questions scored on a Likert scale from 1-4; item scores are summed for a total score ranging from 20 to 80, with higher scores indicating higher anxiety. Change in anxiety was calculated as the score pre-aromatherapy minus the score post-aromatherapy. Higher positive change scores indicate greater reductions in anxiety.
| units on a scale | Lavender Oil | Placebo |
|---|---|---|
| Anxiety Reduction | 0.89 ± .32 | .74 ± .44 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lavender Oil | — | 0/43 (0%) | 0/43 (0%) |
| Placebo | — | 0/45 (0%) | 0/45 (0%) |
93 patients were enrolled into the study, but only 88 had useable data. 43 patients in the lavender arm and 45 in the placebo/unscented oil arm had usable data.
| Age, Continuous(years) | Lavender Oil | Placebo | Total |
|---|---|---|---|
| Mean | 50 (24 to 86) | 48 (22 to 82) | 49 (22 to 86) |
| Sex/Gender, Customized(participants) | Lavender Oil | Placebo | Total |
|---|---|---|---|
| Male | 0 | 0 | 0 |
| Female | 43 | 45 | 88 |
| Race (NIH/OMB)(Participants) | Lavender Oil | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 6 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 28 | 29 | 57 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 6 | 13 |
| American Society of Anesthesiologists (ASA) Physical Status Classification(participants) | Lavender Oil | Placebo | Total |
|---|---|---|---|
| ASA I | 15 | 15 | 30 |
| ASA II | 27 | 29 | 56 |
| ASA III | 1 | 1 | 2 |
Plan to share: No
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